BRAME Blue Ribbon for the Awareness of ME

As you are all now aware, I have resigned from the NICE Guideline Development Group (GDG) on ME/CFS (August 2007). I originally requested that a statement went in the guidelines “Tanya felt unable to agree with the content of these guidelines”, as I felt that I could not sign up to the guidelines, but did not want to resign, as I was, and still am, willing to be part of future re.writes/redrafts, which I feel are inevitable. However this option was not available to me, and therefore I felt that I must resign, as I could not sign up to the guidelines. I hope that you will understand that I was not able to make my decision known until today, the date of publication for the guidelines, as I have always adhered to the confidentiality that was expected from being a member of the GDG.

I know that many of you will question why I did not resign from the GDG sooner, but I have stayed to the end, continuing to highlight the patient experience, and hoping that I could try and make even a small difference, a word or sentence that could be extrapolated and used to help us, and I truly tried. Please believe me when I say that I have never fought harder or shouted louder, I have continually presented biomedical and patient evidence to the group. I fought hard to try and get the Canadian Clinical Guidelines/diagnostic criteria accepted, I used the patient evidence supplied to me, and quoted/brought up some of the thousands of research papers that were dismissed by the York Review.

I do believe that many problems stemmed from the scope of the guidelines and York Review. Given that the aetiology and pathogenesis of the condition were not part of the scope these could not be searched for, and subsequently meant that thousands of papers could not be discussed as part of the process. Just one example of this is GET; the question posed by the York team looked for papers on ‘GET and ME/CFS’, it did not however search for papers on ‘Exercise and ME/CFS’, and this meant that the many papers showing the potential harm of exercise on the bodies of people with ME/CFS, and that people with ME/CFS react adversely to exercise were not picked up, and no matter how many times I brought them up in the meetings, I was told that the scope of the guideline meant that they could not be discussed, creating a slanted view on exercise and ME/CFS, with only the papers on GET being able to be discussed.

Some, but not all, of the areas I fought hard for are the following – you can decide on reading the guidelines whether I won these battles:

The guidelines to acknowledge that this is a physical, organic, neurological illness. The inclusion of this was vital for both patients and doctors, and by omitting this will do more harm, with more doctors continuing the erroneous belief that this is a psycho-somatic/mental health issue. I also fought hard for the inclusion of the WHO classification (ICD10 G93.3) of ME as a neurological illness, and recognised as such by the Department of Health.

For the acknowledgement that there is, at present, no cure, nor is there a management plan which is suitable for all. I am not stating that people do not recover sufficiently to lead a normal life, nor that recovery/improvement is not possible, but that to find a cure we must first understand the underlying condition, until then remission/relapse is always a possibility. Instead of including this vital, and accurate, statement, the erroneous impression is given that GET/CBT can cause people to recover.

The guidelines to recommend the widespread/national use of the Canadian Clinical Guidelines on ME/CFS, in particular the diagnostic criteria, which provide a more accurate diagnosis, whilst still allowing people to be managed and monitored who suffer from Idiopathic Chronic Fatigue Syndrome.

That early diagnosis is vital, but this must be an accurate diagnosis, after the exclusion of all other conditions.

That too many people are mis-diagnosed, which in turn leads to mis-management. I brought up several cases where people who were mis-diagnosed and later died, either through initial mis-diagnosis, mis-management, or the misappropriation of symptoms to ME when they were in fact related to a co-morbid condition.

That patients have the right to refuse or withdraw from any part of their care/management plan, without detriment to their care. This was in the CMO report as well but, as everyone knows, was not adhered to in the real world.

That patients are a partner in their care plan, and that any tests or management plans are mutually agreed, and individually tailored. Most importantly that the patients’ views are important, that they should be listened to, and believed.

That patient evidence is listened to, and respected, particularly for the severely affected and children/young people, for whom there is very little research evidence, apart from patient evidence. I used the 25% Group’s statistics at virtually every meeting – and fought to have these results included in the guidelines.

That any recommendation of CBT is based on flawed research, and goes against patient, and research, evidence:

That the MRC neuroethics committee has expressed concern about CBT, and states that harm has already been caused.

That the majority of patients find CBT unhelpful/harmful, and that person-centred counselling, is the more acceptable form of help in coming to terms and coping with this life changing condition.

That ‘illness beliefs’ have no place with this condition. ME/CFS is a debilitating and chronic organic condition – you cannot ‘believe’ yourself better.

That any recommendation of GET is based on flawed research, and goes against patient, and research, evidence:

There are multiple research papers showing that people with ME react adversely to exercise, and that increasing the cardiac rate, in particular, is extremely dangerous.

That patient evidence has shown that the majority of patients find GET unhelpful/harmful, with more than one patient survey showing over half of patients undertaking GET are made worse.

That patients find pacing activities to be the more helpful approach to managing their condition.

That patients find the bio-medical approach to be the most helpful ie. symptom/pain management, pacing and person-centred counselling – all of which have little or no description in the guidelines.

That patients not only go through different levels of severity, but also different stages of their illness eg. acute, chronic, recovery; and that how a patient reacts to a management plan, or whether increased rest is needed, is dependent not only on their level of severity but on the stage at which their illness is at.

That all patients, but in particular the severely affected, and the long term moderately or severely affected, should undergo regular monitoring and reviewing of their condition, with blood tests routinely done to examine whether any co-morbid blood conditions/nutrient deficiencies are occurring. I also fought for Ferritin, B12 and Folate to be done as standard during diagnosis to pick up underlying anaemias as these are not always indicated by standard blood tests, along with the POTS test.

That the severely affected are largely forgotten and invisible. That the numbers seen in the clinics and GP surgeries are just the tip of the iceberg. The reality is a much greater number than those thought, due to this group being housebound/bedridden – most having bounced around medical and social services – they have usually ended up falling through the system.

That the severely affected have the right to at least the same level of clinical care as afforded to those who are not severely affected ie. because they are bedbound does not mean that they do not have the right to see a consultant or doctor – home visits should be initiated, along with outreach services, and specialist nurses, this does not mean that the severely affected should be managed the same way, but that they should have access to care as others do, although at a domiciliary or in-patient level. That PCTs do not have the funding or resources to deal with this section of the ME community.

That the severely affected, in particular the long-term, vitally need regular follow-up care and monitoring, preferably by a specialist consultant/clinician in ME. I constantly highlighted the multiple problems faced when you are a severely affected person with ME, and the specific needs/care needs of this particularly vulnerable group.

That the severely affected, and the long term moderately and severely affected, have a complex and chronic multi-organ, multi-system illness, with a high probability of co-morbidity, and that fatalities are a real possibility. I also highlighted personal tragedies I was made aware of, as well as the Jason et al paper, showing that people with ME die approximately 25 years younger from cancer and heart problems. Deaths do happen and they should not be swept under the carpet, but should be highlighted, investigated, learned from, and hopefully, with appropriate monitoring, prevented.

The impact that living with ME has, not only on the patient, but also the carer and the family.

The urgent need for research into:

The bio-medical aetiology and pathogenesis of this chronic and complex organic illness.

Sub-grouping – until subgroups are identified and studied we are not going to move much further forward – I constantly highlighted, and sent in the Jason et al paper on sub-grouping.

That the cost of CBT/GET as management strategies is not only much higher financially in an immediate sense, when compared to the bio-medical approach, but also over a longer period of time, with any positives seen as being only short-lived, but more importantly, that most patients find these approaches unhelpful/harmful, which will not only cost the health service more through the deterioration of the patients’ health, and the impact that has on their quality of life, but also in a wider economic sense, due to loss of the ability to work.

I highlighted the multiple cases where the severely affected, and the young, were erroneously and forcibly removed from their homes, or sectioned, and the impact that this causes not only on the patient but the family – this is something that should not happen, and there are fears that the new mental health bill, will actually make things worse – something again that I raised.

I highlighted the lack of appropriate, or in some cases, any, service provision around the country, and that this has been further hampered by the Government’s removal of ring-fenced funding. That many patients do not have a GP, and if they do, many do not believe, or understand, the condition. I also highlighted that, where there is no ME/CFS service, patients are usually, and falsely, referred into the mental health system, where they can remain for years.

I am pleased that the guidelines:

Recognise that it is a patient’s right to choose to refuse or withdraw from any aspect of their care plan without detriment to their care.

The severely affected have the right to care, and that this could be through domicillary visits – although I was extremely disappointed to see that most of the severely affected section in the full document has been removed – as I felt in the draft that this was the section that most closely related to the actual illness ME, and its impact, that we all know and live with.

All patients will be given the offer of referral to a ME/CFS clinic – referrals will only work however:

If there are GPs who believe in the condition and are willing to make a referral

There is the funding for this to occur, and clinics to exist

There are the appropriately trained staff, who truly understand the condition

Where there is the provision of follow-up care/monitoring

That the clinic follows a bio-medical approach to this organic illness – for although there is no agreement on the specific cause of this condition, the majority of research papers/clinicians are in agreement that this is an organic illness, and should be treated as such.

Despite the caveats and recommendations that people will have the right to refuse or withdraw from any aspect of their care plan without detriment to their care, I fear that when this guideline comes out, I, and hundreds of thousands of other patients, will be worse off. I have already heard that the few bio-medical clinics in this country, run by the NHS, will probably become psycho-social therapy centres following this document, with no follow-up care or monitoring for the severely affected. I understand that patients have a choice, but the CMO Report on ME/CFS (Jan 2002) also gave patients the choice, and within weeks of the report coming out, patients were only being offered the ‘evidence based’ approaches, so the only offer to the patient was CBT and GET. I fear that following the publication of the NICE guidelines this will become even more widespread – particularly if targets are released of a percentage of people being expected to take part in different strategies, this, I fear, will cause the SHAs/PCTs to force people into these strategies in order to fulfil their quota – not because it is in the best interest of the patient. I believe that these guidelines, as they stand, will lead to more mis-diagnosis and mis-management, and I fear even more deaths.

I do believe that the guideline has not fully taken into account the patient and bio-medical evidence, because if it had, then it would not be recommending the widespread use of CBT and GET against patient and bio-medical research evidence. It is said that patient evidence is not given high weighting due to it being biased, but I argue that all research can suffer from bias, and can be subject to influence on the results eg. criteria used, cohort of patients chosen etc. all affects the results. I also believe that the scope of the guideline and York Review prevented bio-medical research being taken into account.

There are many issues which meant that I could not sign up to the guidelines, including not acknowledging ME as a physical neurological illness, the lack of proper diagnostic criteria, the ignoring/devaluing of patient evidence, and the recommendation of CBT and GET, all of which mean that I cannot in my conscience support the content of these guidelines.

I have stated to NICE that I am more than happy to once more represent patients as part of any rewrite or review of the guidelines – I believe that this is inevitable, and needs a more balanced approach taken, taking into account all evidence. Until the research papers which erroneously promote CBT and GET, and the false premise on which these are based, are acknowledged for their flaws, and the patient evidence is given correct weighting, then the hundreds of thousands of patients I represent, and the thousands of bio-medical research papers, will not be given proper evaluation and listened to.

I thank NICE for allowing me to be part of the process. I conscientiously worked long and hard, and took my position as patient representative very seriously. I have tried my hardest to fight on behalf of the patients, at considerable detriment to my own health (2½ years of constant trips to London to attend meetings, and the huge amount of work inbetween), to give the patient viewpoint/evidence and provide the group with bio-medical research/evidence. I hope that you will all understand my reasons behind my decision to remain with the group till the end, and my decision to subsequently resign. I thought long and hard about the consequences of my decision, but ultimately I had to act in, what I felt were, the best interests of my fellow patients.